Home
» 
Product information
» Info: Pharmaceutical set
» PHARMACEUTICAL AND BIOTECHNOLOGY PRODUCT GUIDE
PHARMACEUTICAL AND BIOTECHNOLOGY PRODUCT GUIDE
Save time when you are choosing pharmaceutical and biotechnology products.
At Béné Inox, accompanying our customers in the definition of their requirements is our priority.
Our guide will help you to choose from our selection of pharmaceutical and biotechnology industry products.
You can save time by following our guide !
1. Application environment :
We have brought together in one selection of products all of our fittings/connectors, piping accessories, valves, tank accessories and piping which are dedicated and adapted to pharmaceutical product manufacturing including vaccinations, reagents, medicines, as well as purified water or injectable water (WFI: water for injectable preparations).
This product selection can also be used for chemical and cosmetic manufacturing applications.
All part dimensions are in imperial inches (also called O.D.) where 1'' = 25.4mm.
All of our products in this selection comply with the American ASME BPE standard (please see the Standard Information section below).
This range is not the same as our Béné Inox 63 range which contains clamp fittings/connectors
which comply with ISO, SMS and DIN standard dimensions, as these are different to the imperial inches used by the ASME BPE standard.
In a sector where hygiene is the most important production process consideration,
we have made sure that the majority of the models in our pharmaceutical and biotechnology range
can be cleaned without you having to remove them (CIP - Cleaning in place) and can undergo in-situ sterilisation (SIP - Sterilisation in Place).
2. Usage conditions and performance :
You should take the following elements into account to optimise the design of your pharmaceutical or biotechnology process :
Step 1 : Temperature and Pressure
The products in this range can be used at temperatures which vary between -200°C and +260°C.
Please take note : process temperature will play a decisive role in the choice of gasket for each different part.
Gaskets are proposed in four materials in this range :
- EPDM (from -50°C to +135°C)
- PTFE (from -200°C to +260°C)
- FKM (from -15°C to +250°C)
- Platinum silicone (from -55°C to +200°C)
(This gasket is platinum hardened to limit the risk of volatile organic compound (VOC) transfer. This means that the release rate of VOCs into the transported fluid will be a lot lower than the levels advised in the applicable standards).
NB. : your fluid type will also influence the gasket choice : See Step 3 below
You will need to be particularly careful about your choice of assembly method and its maximum pressure rating (nominal pressure, working pressure or operating pressure at 20°C) to make sure that it is suitable for the pressure requirements of your process.
1. CLAMP collar assembly
CLAMP collar connectors give perfect sealing between pipes. This sealing is obtained by gasket compression.
CLAMP collars are commonly used in the pharmaceutical industry.
You must tighten collars in a controlled way so that the collar's faces remain parallel.
If you tighten CLAMP collars incorrectly you could cause intrusion or gasket removal problems, and this could result in ASME BPE tolerances being exceeded.
- Simple and double articulation CLAMP collars have a pressure rating of 9 to 83 bars depending on their diameter
- Bolted HP CLAMP collars have a pressure rating of 40 to 83 bars depending on their diameter
2. Orbital welding assembly :
VPlease consult our MAP document (maximum allowed internal pressure for piping system pipes) which gives the maximum allowed pressures for all main piping dimensions.
You can also assemble these collars with manual welding, however orbital welding is more hygienic and more easily repeated than manual welding. These points are both particularly important for interventions that are carried out in clean-room environments.
Step 2 : Flow rate for calculating internal piping diameter (cross-section).
The recommended flow velocity is specific to each fluid type.
For example, it is generally recommended to use a flow velocity of 2-3m/s in piping to avoid too turbulent flow.
Once you have defined the flow rate, you can establish the relationship between fluid velocity and cross-section, so that you can calculate the piping diameter DN.
After you have done this, please refer to the dimensioning table above (in section 1. Application environment).
Step 3 : Fluid type
In a pharmaceutical process, you need to reduce retention zones that could create biofilms (communities of micro-organisms which are attached to surfaces) as much as possible, so the type of fluid transported and its purity level are decisive factors for selecting a fitting's surface roughness and finish.
Our range includes two types of surface finish for this selection of 316L stainless steel products: SF1 - Ra 0.51µm (Mechanical polishing - Brushed look) and SF4 - Ra 0.375µm (Electropolishing - Shiny look).
The type of fluid will also allow you to check if it is compatible with your gasket material.
The connector's gasket has a very important role in ensuring your process remains sealed/watertight.
If a gasket falls apart, it could pollute the fluid and also cause the process to leak.
>> Please click here to read documentation about this subject: indicative material chemical resistance
You can also find information about the certification of our gaskets directly on our product information sheets.
**********************************************************************************
Certificate information :
Each Béné Inox ASME BPE part we deliver has a certificate :
- For stainless steel parts: we provide a 3.1 material certificate which complies with EN10204, including part surface roughness.
- For gaskets and diaphragms: we provide a 2.1 material certificate which complies with EN 10204, including CE1935/2004 and USP Class IV chapters 87 and 88 conformity declarations and a material data sheet (for polymer products)
Standards information :
The American ASME BPE (American society of mechanical engineers - BioProcessing Equipment) standard is dedicated to the pharmaceutical, biotechnology and cosmetic industries.
This standard specifies the imposed requirements for these industries which require relatively high hygiene levels.
This standard covers: materials, process design and manufacture, dimensions, surface finishes, tests and certifications.
The ASME BPE standard fixes product design and manufacture specifications for fluid processes used in industries which require a specific level of purity and microbe charge control.
Due to this we supply the metal products which meet this standard in individual packaging (with pipe ends plugged and colour labelling according to each part's surface finish) and all pipes are cleaned, have their ends plugged and are wrapped in film.
Do you need any more information ?
>> Please contact us for more information on 0033 4 78 90 48 22 or by filling in our request for information form here
At Béné Inox, accompanying our customers in the definition of their requirements is our priority.
Our guide will help you to choose from our selection of pharmaceutical and biotechnology industry products.
You can save time by following our guide !
1. Application environment :
We have brought together in one selection of products all of our fittings/connectors, piping accessories, valves, tank accessories and piping which are dedicated and adapted to pharmaceutical product manufacturing including vaccinations, reagents, medicines, as well as purified water or injectable water (WFI: water for injectable preparations).
This product selection can also be used for chemical and cosmetic manufacturing applications.
All part dimensions are in imperial inches (also called O.D.) where 1'' = 25.4mm.
All of our products in this selection comply with the American ASME BPE standard (please see the Standard Information section below).
This range is not the same as our Béné Inox 63 range which contains clamp fittings/connectors which comply with ISO, SMS and DIN standard dimensions, as these are different to the imperial inches used by the ASME BPE standard.
In a sector where hygiene is the most important production process consideration,
we have made sure that the majority of the models in our pharmaceutical and biotechnology range
can be cleaned without you having to remove them (CIP - Cleaning in place) and can undergo in-situ sterilisation (SIP - Sterilisation in Place).
2. Usage conditions and performance :
You should take the following elements into account to optimise the design of your pharmaceutical or biotechnology process :
Step 1 : Temperature and Pressure
The products in this range can be used at temperatures which vary between -200°C and +260°C.
Please take note : process temperature will play a decisive role in the choice of gasket for each different part.
Gaskets are proposed in four materials in this range :
- EPDM (from -50°C to +135°C)
- PTFE (from -200°C to +260°C)
- FKM (from -15°C to +250°C)
- Platinum silicone (from -55°C to +200°C)
(This gasket is platinum hardened to limit the risk of volatile organic compound (VOC) transfer. This means that the release rate of VOCs into the transported fluid will be a lot lower than the levels advised in the applicable standards).
NB. : your fluid type will also influence the gasket choice : See Step 3 below
You will need to be particularly careful about your choice of assembly method and its maximum pressure rating (nominal pressure, working pressure or operating pressure at 20°C) to make sure that it is suitable for the pressure requirements of your process.
1. CLAMP collar assembly
CLAMP collar connectors give perfect sealing between pipes. This sealing is obtained by gasket compression.
CLAMP collars are commonly used in the pharmaceutical industry.
You must tighten collars in a controlled way so that the collar's faces remain parallel.
If you tighten CLAMP collars incorrectly you could cause intrusion or gasket removal problems, and this could result in ASME BPE tolerances being exceeded.
- Simple and double articulation CLAMP collars have a pressure rating of 9 to 83 bars depending on their diameter
- Bolted HP CLAMP collars have a pressure rating of 40 to 83 bars depending on their diameter
2. Orbital welding assembly :
VPlease consult our MAP document (maximum allowed internal pressure for piping system pipes) which gives the maximum allowed pressures for all main piping dimensions.
You can also assemble these collars with manual welding, however orbital welding is more hygienic and more easily repeated than manual welding. These points are both particularly important for interventions that are carried out in clean-room environments.
Step 2 : Flow rate for calculating internal piping diameter (cross-section).
The recommended flow velocity is specific to each fluid type.
For example, it is generally recommended to use a flow velocity of 2-3m/s in piping to avoid too turbulent flow.
Once you have defined the flow rate, you can establish the relationship between fluid velocity and cross-section, so that you can calculate the piping diameter DN.
After you have done this, please refer to the dimensioning table above (in section 1. Application environment).
Step 3 : Fluid type
In a pharmaceutical process, you need to reduce retention zones that could create biofilms (communities of micro-organisms which are attached to surfaces) as much as possible, so the type of fluid transported and its purity level are decisive factors for selecting a fitting's surface roughness and finish.
Our range includes two types of surface finish for this selection of 316L stainless steel products: SF1 - Ra 0.51µm (Mechanical polishing - Brushed look) and SF4 - Ra 0.375µm (Electropolishing - Shiny look).
The type of fluid will also allow you to check if it is compatible with your gasket material.
The connector's gasket has a very important role in ensuring your process remains sealed/watertight.
If a gasket falls apart, it could pollute the fluid and also cause the process to leak.
>> Please click here to read documentation about this subject: indicative material chemical resistance
You can also find information about the certification of our gaskets directly on our product information sheets.
**********************************************************************************
Certificate information :
Each Béné Inox ASME BPE part we deliver has a certificate :
- For stainless steel parts: we provide a 3.1 material certificate which complies with EN10204, including part surface roughness.
- For gaskets and diaphragms: we provide a 2.1 material certificate which complies with EN 10204, including CE1935/2004 and USP Class IV chapters 87 and 88 conformity declarations and a material data sheet (for polymer products)
Standards information :
The American ASME BPE (American society of mechanical engineers - BioProcessing Equipment) standard is dedicated to the pharmaceutical, biotechnology and cosmetic industries.
This standard specifies the imposed requirements for these industries which require relatively high hygiene levels.
This standard covers: materials, process design and manufacture, dimensions, surface finishes, tests and certifications.
The ASME BPE standard fixes product design and manufacture specifications for fluid processes used in industries which require a specific level of purity and microbe charge control.
Due to this we supply the metal products which meet this standard in individual packaging (with pipe ends plugged and colour labelling according to each part's surface finish) and all pipes are cleaned, have their ends plugged and are wrapped in film.
Do you need any more information ?
>> Please contact us for more information on 0033 4 78 90 48 22 or by filling in our request for information form here